NCT00861250

Brief Summary

The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Mar 2009

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 17, 2016

Status Verified

December 1, 2014

Enrollment Period

5.8 years

First QC Date

March 12, 2009

Last Update Submit

June 15, 2016

Conditions

Multiple Myeloma

Keywords

Bortezomib plus dexamethasone induction therapyAutologous stem cell transplantationMolecular remission

Outcome Measures

Primary Outcomes (1)

  • Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR

    Before ASCT and 3-4 months after ASCT and then with 3-4 months interval

Study Arms (1)

Vel/Dex

EXPERIMENTAL
Drug: bortezomib + dexamethasone

Interventions

bortezomib + dexamethasoneDRUG

Bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4, 9-12 in cycles 1- 2, then bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4 in cycles 3-4, total number of cycles is 4, followed by HDT with ASCT

Also known as: VelcadeTM
Vel/Dex

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic multiple myeloma
  • Age 18-65 years
  • Written informed consent

You may not qualify if:

  • WHO performance status ≥ 2, unless related to MM
  • Severe cardiac dysfunction
  • History of hypotension
  • Serious medical or psychiatric illness
  • Severe hepatic dysfunction
  • Severe polyneuropathy ≥ grade 2
  • Active, uncontrolled infection
  • Previously treated with chemotherapy or extensive radiotherapy for MM
  • Known HIV positivity
  • Severe renal dysfunction with need of dialyses
  • History of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer
  • Female patients who are pregnant or nursing
  • Male or female patients of reproductive potential who are not practising effective means of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33 521, Finland

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

BortezomibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Raija H Silvennoinen, MD

    Tampere University Hospital, Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

June 17, 2016

Record last verified: 2014-12

Locations

FI(1)